id	author	title	date	pages	extension	mime	words	sentence	flesch	summary	cache	txt
cord-286237-x6dr6rsh	Maes, Bastiaan	Treatment of severely ill COVID-19 patients with anti-interleukin drugs (COV-AID): A structured summary of a study protocol for a randomised controlled trial	2020-06-03		.txt	text/plain	11261	428	42	Ethical and legal aspects The study will be conducted cfr the latest version of the ICH E6 (R2) GCP guidelines, creating a standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical studies that provides assurance that the data and reported results are accurate and that the rights, integrity and confidentiality of study subjects are protected. Monitoring services will consist of the following (non-exhaustive list): -review of informed consents and the followed process -check on recruitment status -checking for protocol deviations/violations -checking GCP compatibility -check on safety reporting compliance -IMP handling and storage -review of study data … This study can be inspected at any time by regulatory agencies during or after completion of the study.	cache/cord-286237-x6dr6rsh.txt	txt/cord-286237-x6dr6rsh.txt
